Andrew Blauvelt, MD, MBA, is a board-certified dermatologist and President of Oregon Medical Research Center. He was a long-standing member of the medical advisory board of the National Psoriasis Foundation, and is an elected member of the International Psoriasis Council. His laboratory and clinical research expertise in immunology, infectious diseases, and psoriasis, making him a key expert for numerous pharmaceutical companies and a reputable educator for dermatologists across the country and the world. Dr Blauvelt joined The Dermatologist to discuss his recent study on risankizumab administered as a 150 mg formulation by prefilled syringe or by an autoinjector for moderate to severe plaque psoriasis.
Based on your recent findings,1 how can a patient-controlled single self-injection biologic improve adherence and long-term management of psoriasis?
First, we know that psoriasis is a chronic disease. Since it's a chronic disease with no cure, it requires chronic therapy. The best chronic therapies that we have now are biologics, which are injectable. One of the criteria that we look at when we're explaining different biologics to patients is convenience or acceptability.
First, we talk about efficacy and safety for all the biologics, but then we address the convenience factor. These would be: how many shots are given? How often are they given? What kind of device are they given by? That's in that third category, what we call the convenience category. That sometimes tips the balance over into one biologic or another as a consideration when we're trying to decide which one to choose.
Psoriasis can be embarrassing and debilitating to a patient’s quality of life. In what ways can the different dosing schedules of advanced therapies (Q12W vs Q8W vs Q4W) modify patients’ quality of life?
Some biologics are given as frequently as every week. The least frequent ones are given every 12 weeks. We have a range. There are 11 biologics on the market, given anywhere from weekly dosing to every 12-week dosing.
Most surveys of patients have suggested that it is an issue administering the drug more often, and that fewer shots are preferred. We especially see that difference in the drugs that are dosed every week or every two weeks as patients tend not to like those choices.
When you get to once a month versus once every two months versus once every three months, the preference differences are small. Patients prefer every two months a little bit better than every month, and every three months a little bit better than every two months. Thus, the monthly dosing or fewer is the category that most patients want to be in for a chronic therapy. It makes sense. We do many things once a month. We do many things quarterly in our lives. That kind of dosing fits well into everyday life.
Study1 has noted that, “Acceptability of self-injection was high.” Why do you think this was so among patients?
I think a lot of dermatologists and a lot of the patients freak out when they hear "needle;” nobody likes needles. In the case of biologics, we see some dermatologists who don't like to prescribe biologics or some patients who say, "No, I'll never want a needle." What is not always fully appreciated, however, is that the biologic needles are very small. They're not the bigger needles that are used to draw blood during phlebotomy or ones that are used for vaccines. The other thing about the shots is that they are given subcutaneously, which is really just underneath the surface of the skin. They're not given deeply into the muscle like a vaccine. Those shots hurt much more. When I give patients that information by saying, "Yes, it is a needle, but it's a tiny needle. It's just under the surface of the skin," what I find is that they quickly realize that it's no big deal. After the first few, they're completely comfortable with it and have gotten over that fear very easily.
Indeed, the needle phobia can be taken too far and be used as a reason not to use a high-quality medicine. As we know now, there are many great medicines that are given subcutaneously, not just in dermatology, but in medicine in general. I really encourage both patients and doctors to minimize the fear of needles.
Are there any limitations with using self-administered biologic therapies?
I think one of the limitations of self-administered biologics is that it requires refrigeration. Think about it. If you're on a medicine that's once a month, for a year's supply, you're going to have 12 syringes in your refrigerator versus a drug that's given every three months, where you're going to have four syringes every year in your refrigerator.
If you happen to be on a camping trip, let's say, or something like that where refrigeration is limited, that could be an issue. If you're traveling, the drug can stay at room temperature for a while and still be OK. Still, travel could be a potential issue.
Then some patients just like to have it done in the doctor's office. That's OK too, because then we know we can stay on track with compliance. When the patients are doing it and not the doctor's office, sometimes compliance can be compromised. That can affect efficacy, of course, if patients are not giving the shots when they're supposed to.
It requires time each time you're doing it. For example, risankizumab, up until this study that we're talking about now, was given as two shots every time it was given2. Risankizumab is in that category of every-12-week dosing, but we only had 75 milligrams in each syringe prior to this time. The currently studied dose was 150 milligrams per shot. Patients will now only have to do one shot every 12 weeks.
What we really studied here was a prefilled syringe that had 150 milligrams in it, so all the medicine was in a single syringe. Then, in another study3 also described in this paper, we had an autoinjector, which is even a simpler device, where patients just pressed a button, basically, to deliver their 150 milligrams. This paper describes these two studies with a single prefilled syringe or a single autoinjector shot for risankizumab, which are both improvements over what we have right now on the market.
Regarding plaque psoriasis, what key takeaways do you want to share with other dermatologists?
We have amazing medicines for plaque psoriasis now. The newer biologics, in particular the ones that block either IL-17 or IL-23, are where it's at. If there are dermatologists who are not using biologics and using, what I call, 20th century medicines in the 21st century, then I think that's not good for their patients.
It's poor management of their patients when we have such terrific drugs available, not only from an efficacy point of view, but from a safety point of view as well. Then, when we have this plethora of incredible medicines, they are all competing with one another. Of course, the companies are competing with one another. They're always trying to improve the efficacy, the safety, and the convenience of these medicines.
This study is just one more improvement on an already good drug. Risankizumab is an excellent drug. They've made it even easier with a 150 milligram syringe or autoinjector so that patients only have to give one shot.
Things seem to be getting better and better as far as all three of those main areas—the efficacy, safety, and convenience of these drugs. So, my main message is don't be afraid to use biologics. You'll have very happy patients if you are using one of the more modern biologics.
References:
1. Blauvelt A, Gordon KB, Lee P, et al. Efficacy, safety, usability, and acceptability of risankizumab 150 mg formulation administered by prefilled syringe or by an autoinjector for moderate to severe plaque psoriasis. J Dermatolog Treat. Published online May 5, 2021. doi:10.1080/09546634.2021.1914812
2. Gordon KB, Strober B, Lebwohl M, et al. Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled phase 3 trials. Lancet. 2018;392(10148):650-661. doi:10.1016/S0140-6736(18)31713-6
3. Lon HK, Cheng L, Nudurupati S, et al. Pharmacokinetic Comparability of Risankizumab Formulations in Prefilled Syringe and Auto-injector for Subcutaneous Injection. Clin Ther. 2021;43(3):629-636. doi:10.1016/j.clinthera.2021.01.009
